Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00114920
First received: June 20, 2005
Last updated: February 16, 2007
Last verified: November 2006
  Purpose

The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for twelve weeks.

A second purpose is to evaluate the safety of the drug.


Condition Intervention Phase
Warts
Drug: Resiquimod
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel for the Treatment of Common Warts in Adults

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Clearance of treated common wart(s)

Secondary Outcome Measures:
  • Partial clearance of treated common wart(s)
  • Wart recurrence

Estimated Enrollment: 88
Study Start Date: March 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of common warts
  • Two forms of birth control

Exclusion Criteria:

  • Pregnant or breast feeding
  • Other types of wart(s), ie. plantar
  • Currently participating in another clinical study
  • Chronic viral hepatitis B or C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114920

Locations
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47713
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00114920     History of Changes
Other Study ID Numbers: 1508-RESI
Study First Received: June 20, 2005
Last Updated: February 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Wart(s)
Adults
Common Wart(s)

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014